Abgeschickt von Oliver Nolte am 28 Oktober, 2003 um 15:41:51
I have just discussed with the co-ordination centre for clinical trials in Heidelberg about the design of a clinical trial with autovaccines in humans. It seems that the following design would be the most appropriate: two study groups will be defined: osteomelitis and furunculosis. Each study group is divided into two treatment groups, both receiving antibiotic drugs as the most accepted treatment at this time. One treatment group would receive the true autogenous vaccines whilst the other would receive a placebo instead of an autogenous vaccine. This would provide a proper study design in terms of a pilot study, leaving the window open for a more sophisticated study in a follow-up project.
Questions to those members applying autogenous vaccines in human medicine and contributing to workpackage 3 to 5:
(1) Do you think that this design is possible in your centre/country.
(2) Do you have any literature at hand teaching how many percent of patients treated with antibiotics against osteomyelitis do not show clinical progress?